NDC codes

FDA NDC Directory
Product NDC (as listed)54766-829Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54766-0829Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
54766-829-04547660829045476608290459 mL in 1 BOTTLE, PLASTIC (54766-829-04)Marketed from Aug 5, 2015

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Analpram HC
Generic name (nonproprietary)
hydrocortisone acetate and pramoxine hydrochloride
Active ingredients
Hydrocortisone acetate — 25 mg/mLPramoxine hydrochloride — 10 mg/mL
Dosage form
Lotion
Route
Topical
Labeler
Sebela Pharmaceuticals Inc.NDC labeler code 54766
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 085979
Marketing start
Marketing end
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 54766-829_431483ef-821d-1ef3-e063-6394a90ad31eSPL ID 431483ef-821d-1ef3-e063-6394a90ad31eSPL set ID 1469733e-1723-4b8c-be33-ed8dfafd65e2RxCUI 1234512, 1360956UNII 3X7931PO74, 88AYB867L5
Pharmacologic class
Corticosteroid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N454766082904 followed by a unit qualifier and the quantity

Package 54766-0829-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54766-829

What is NDC 54766-829?
54766-829 is the product NDC for Analpram HC, Hydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mL lotion, listed with the FDA by Sebela Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Analpram HC (Hydrocortisone acetate and pramoxine hydrochloride).
What is the active ingredient?
Hydrocortisone acetate, Pramoxine hydrochloride.
Who is the labeler?
Sebela Pharmaceuticals Inc., NDC labeler code 54766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Analpram HC?
4 other product NDCs are listed under this name. See all Analpram HC NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Analpram HC NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Analpram HChydrocortisone acetate and pramoxine hydrochlorideHydrocortisone acetate 25 mg/g; Pramoxine hydrochloride 10 mg/gCreamTopicalLegacy Pharma USA Inc.83107-01983107-0019-1283107-0019-30
Analpram HChydrocortisone acetate and pramoxine hydrochlorideHydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/gCreamTopicalLegacy Pharma USA Inc.83107-01883107-0018-01
Analpram HChydrocortisone acetate and pramoxine hydrochlorideHydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mLLotionTopicalLegacy Pharma USA Inc.83107-02083107-0020-02
Analpram HChydrocortisone acetate and pramoxine hydrochlorideHydrocortisone acetate 25 mg/g; Pramoxine hydrochloride 10 mg/gCreamTopicalSebela Pharmaceuticals Inc.54766-79954766-0799-65

Other NDCs under ANDA 085979

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 085979
ProductStrengthForm · routeLabelerProduct NDC
Analpram HChydrocortisone acetate and pramoxine hydrochlorideHydrocortisone acetate 25 mg/g; Pramoxine hydrochloride 10 mg/gCreamTopicalLegacy Pharma USA Inc.83107-019
Analpram HChydrocortisone acetate and pramoxine hydrochlorideHydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mLLotionTopicalLegacy Pharma USA Inc.83107-020
Pramosonehydrocortisone acetate and pramoxine hydrochlorideHydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mLLotionTopicalLegacy Pharma USA Inc.83107-021

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